RU2684841C2 - Placement system implantable fastening element, method for assembly of such system and fastening element (options) - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: accommodation system for the percutaneous delivery and implantation of a fastener of an implantable element for monitoring and / or processing data on the physiological conditions of the patient’s body or for delivering a therapeutic preparation contains the cannula of an input device, a hollow pusher having a hole, a shell and a fastener placed inside the hollow pusher. Fastener contains a proximal stabilizing element having a compressed configuration and a deployed configuration, a distal stabilizing element having a compressed configuration and a deployed configuration, a jumper between the proximal stabilizing element and the distal stabilizing element. In a compressed configuration, the proximal stabilizing element passes through the opening of the hollow pusher, wherein the fastening element has a positioning console for fastening the fastening element extending from the distal stabilizing element to which the implantable element is attached. Method of assembling the placement system for the percutaneous delivery and implantation of the fastener of the implantable element to monitor and / or process data on the physiological conditions of the patient’s body or to deliver a therapeutic agent containing a cannula, a shell, a hollow pusher with a hole and a fastener, moreover, the fastening element has a proximal stabilizing element, a distal stabilizing element and a jumper between them, consists in loading the fastening element into the hollow plunger in such a way that the proximal stabilizing element passes through the hole, and pushing the casing along the pusher and proximal stabilizing element to press the proximal stabilizing element against the outer surface of the pusher. Implantable fastener of an implantable element for monitoring and / or processing data on the physiological state of the patient's body or for delivery of a therapeutic drug in the first embodiment contains a proximal stabilizing element extending from the proximal end to the distal end, a distal stabilizing element extending from the proximal end to the distal end, a jumper extending between the distal end of the proximal stabilizing element and the proximal end of the distal stabilizing element, and a positioning console for attaching the implantable element extending from the proximal end of the distal stabilizing element. Proximal and distal stabilizing elements have a compressed configuration and are configured to adopt a deployed configuration. Proximal end of the distal stabilizing element is distal relative to the distal end of the proximal stabilizing element. Implantable fastener of an implantable element for monitoring and / or processing data on the physiological state of the patient's body or for delivery of a therapeutic drug in the second embodiment, contains a proximal stabilizing element extending from the proximal end to the distal end, a distal stabilizing element extending from the proximal end to the distal end, a jumper extending between the distal end of the proximal stabilizing element and the proximal end of the distal stabilizing element, and a positioning console for attaching the implantable element extending from the proximal end of the distal stabilizing element. Positioning console is distal relative to the distal end of the proximal stabilizing element, while the proximal and distal stabilizing elements have a compressed configuration and are configured to adopt a deployed configuration.EFFECT: inventions provide the possibility of implanting a detector without the need to use X-ray or ultrasound for guiding while reducing the procedure time, simplifying the procedure, increasing the probability of a successful outcome and increasing safety.20 cl, 18 dwg

Description

TECHNICAL FIELD

[0001] The present invention relates to a system and method for implanting and fixing a small implantable element for monitoring and / or processing data on the physiological states of a patient's body. In addition, the present invention describes a new fastener designed to accommodate a small implantable element in the desired location in the wall of the target tissue of the patient's body. The present invention also relates to a method of implanting a fastener directly into the target wall of the body and securing the fastener in a given place without displacement during the entire service life of this fastener.

BACKGROUND

[0002] Percutaneous-delivered deployment systems are used to embed implantable devices in the body lumen. In general, such a deployment system comprises a catheter, an implantable device and an element for releasing an implantable device at a target location, such as, for example, described in published US patent application No. 2003/0125790 and in published US patent application No. 2008/0071248 The deployment system is placed in the catheter, and this catheter provides the ability to move the system to the target site, in which the implantable device is released. The implantable device remains in the patient's body to perform its objective function after removing the deployment system.

[0003] It is important that the implantable device be securely attached to the target site before the deployment system releases the device. A device built with insufficient reliability can shift and create a serious danger to the health of the patient, especially if the device migrates from the implantation site. An inadequately embedded device that circulates in the body can cause serious damage, including acute myocardial infarction, stroke, or organ failure. Thus, there is a need for a fastener and a deployment system that ensure reliable implantation and fixation of the device in the body in a fixed place without displacement during the entire service life of the device. In addition, there is a need for a fastener element that provides deployment of an implantable device with minimal damage to the wall of an organ of the body. In addition, there is a need for a fastener that provides the necessary orientation of the device relative to the lumen of the body without moving or adjusting the implanted device after it is deployed in the lumen.

[0004] Such a fastening system is preferable for the clinician, to whom it provides the ability to implant and secure the implantable device with the necessary orientation through the delivery system containing the cannula to simplify deployment while reducing the risk of the device moving over time. In addition, such a system can eliminate the need for a subsequent procedure for restoring the displaced implantable device, as it happens if the device is unreliable implanted by means of fastening means, or moving the implantable device to determine the required orientation of the device relative to the lumen. For example, known methods for monitoring portal pressure in the liver and detecting malignant hypertension are not satisfactory and generally cover the indirect measurement of portal venous pressure in the liver venous system due to the difficulty of accessing the target site for direct implantation of the monitoring device. In addition, there are no known methods of implantation of the control device. Thus, a system that is capable of reliably and safely implanting a portal pressure detector, for example, could reduce the complexity of the procedure and alleviate the need for postoperative treatment, thereby increasing the likelihood of favorable outcomes for the patient.

[0005] Thus, there is a need for a fastening system that provides a simple, safe and reliable implantation of the device in a fixed place with the necessary orientation of the device.

DISCLOSURE OF INVENTION

[0006] This problem is solved by creating an accommodation system for percutaneous delivery and implanting a fastener, which according to the invention comprises an input device cannula, a hollow plunger having an opening, a shell and a fastening element placed inside the hollow plunger and containing a proximal stabilizing element having a compressed configuration and unwrapped configuration, distal stabilizing element having a compressed configuration and unfolded configuration, a jumper between the proximal stabilizing the stabilizing member and the distal member, wherein in the compressed configuration, proximal the stabilizing element passes through the opening of the hollow pusher.

[0007] Preferably, the proximal stabilizing element is pressed against the outer surface of the pusher.

[0008] Preferably, the proximal stabilizing element is wound through the hole.

[0009] Preferably, the hole contains a slot extending along the longitudinal axis of the pusher.

[0010] Preferably, the hole contains a neck perpendicular to the slot.

[0011] Preferably, the fastener has a positioning console extending from a distal stabilizing element.

[0012] Preferably, an implantable element is attached to the positioning console.

[0013] Preferably, the implantable element is a sensor.

[0014] Preferably, the fastener has a height that is less than or equal to 20 mm, and a diameter that is 0.01 mm to 10 mm, in an unfolded configuration.

[0015] In addition, this problem is solved by creating a method for assembling an accommodation system comprising a cannula, a shell, a hollow plunger with a hole and a fastening element, the fastening element having a proximal stabilizing element, a distal stabilizing element and a jumper between them, while according to the method : load the fastener into the hollow plunger in such a way that the proximal stabilizing element passes through the hole, and push the casing along the plunger and the proximal stabilizing element to Press the proximal stabilizing element against the external surface of the pusher.

[0016] Preferably, according to the method, the hole comprises a slot and a neck, while further the pusher is rotated to align the neck of the hole with the proximal stabilizing element.

[0017] Preferably, the shell is further removed by removing the compression from the proximal stabilizing element.

[0018] Also according to the invention, an implantable fastener is provided comprising a proximal stabilizing element extending from the proximal end to the distal end, a distal stabilizing element extending from the proximal end to the distal end, a bridge passing between the distal end of the proximal stabilizing element and the proximal end of the distal stabilizing element, and a positioning console extending from the proximal end of the distal stabilizing element, wherein The proximal and distal stabilizing elements have a compressed configuration and are configured to adopt a deployed configuration, and the proximal end of the distal stabilizing element is distal relative to the distal end of the proximal stabilizing element.

[0019] The fastener preferably has a height of less than or equal to 20 mm and a diameter that is 0.01 mm to 10 mm in a deployed configuration.

[0020] Preferably, the positioning console has a compressed state and a unrolled state.

[0021] Preferably, a small implantable element is attached to the positioning console.

[0022] Preferably, the small implantable element is a sensor.

[0023] The fastener preferably further comprises a first ring at the distal end of the web and a second ring at the proximal end of the web.

[0024] Preferably, the distal stabilizing element and the positioning cantilever extend from the first ring, and the proximal stabilizing element extends from the second ring.

[0025] Preferably, the first ring is larger than the second ring.

[0026] According to the invention, an embodiment of an implantable fastener comprises a proximal stabilizing element extending from the proximal end to the distal end, a distal stabilizing element extending from the proximal end to the distal end, a web extending between the distal end of the proximal stabilizing element and the proximal end of the distal stabilizing element and a positioning console extending from the proximal end of the distal stabilizing element, with the position niruyuschaya console is distal relative to the proximal distal end of the stabilizing element, wherein the proximal and distal stabilizing elements have a compressed configuration, and are arranged to decision deployed configuration.

[0027] the Present invention provides the advantages of reducing the time of the procedure, simplify the procedure, increase the likelihood of a successful outcome and increase safety. The present invention is an additional advantage consisting in the possibility of implantation of the detector without the need to use radiography or ultrasound for guidance.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG. 1A shows a fastener according to the present invention in a fully compressed state.

[0029] FIG. 1B shows the fastening element of FIG. 1A, in a fully expanded state.

[0030] FIG. 2A shows a fastener according to the present invention in a fully compressed state.

[0031] FIG. 2B shows the fastening element of FIG. 2A, in a fully expanded state.

[0032] FIG. 3A shows a fastener according to the present invention in a fully compressed state.

[0033] FIG. 3B shows the fastening element of FIG. 3A, fully unfolded.

[0034] FIG. 4 shows a fastener according to the present invention in a compressed state.

[0035] FIG. 5 shows a fastener according to the present invention in a compressed state.

[0036] FIG. 6 shows a fastener according to the present invention in a compressed state.

[0037] FIG. 7 shows a ring and stabilizing elements according to the present invention in a compressed state.

[0038] FIG. 7A shows various perspective views of a ring and stabilizing elements according to the embodiment of FIG. 8 in the expanded state.

[0039] FIG. 8 shows various embodiments of rings and stabilizing elements arranged on the ring in the unfolded state.

[0040] FIG. 8A shows a top view of various embodiments of stabilizing elements and rings according to the present invention.

[0041] FIG. 9A shows one embodiment of a fastener rod, a second ring, and a first ring according to the present invention.

[0042] FIG. 9B shows the fastener rod, the second ring and the first ring of FIG. 10A, in the expanded state.

[0043] FIG. 9C shows another embodiment of a fastener rod, a second ring, and a first ring according to the present invention.

[0044] FIG. 9D shows a fastener deployed at a target location having a thin wall of fabric.

[0045] FIG. 9E shows a fastener deployed at another target location having a thick fabric wall.

[0046] FIG. 10 shows a cannula of an input device with a fastener loaded in it according to the present invention, inserted into the wall of the target area.

[0047] FIG. 10A shows the cannula of the input device of FIG. 12, the fastening element being shown in a state of partial deployment, with the first stabilizing element and the positioning console deployed in the interior of the wall of the target portion.

[0048] FIG. 10B shows the cannula of the input device of FIG. 13, the fastening element being shown in a fully deployed state, with the second stabilizing element deployed from the outside of the vessel wall, and the first stabilizing element and the positioning console deployed in the inside of the wall of the target portion.

[0049] FIG. 11 shows the cannula of an insertion device with a fastener loaded in it according to the present invention.

[0050] FIG. 12A shows the trigger according to the present invention in a pre-deployment state.

[0051] FIG. 12B shows the trigger of FIG. 12A in a state of partial deployment with a shell pulled from the pusher.

[0052] FIG. 13A shows the trigger according to the present invention.

[0053] FIG. 13B shows the trigger of FIG. 13A in a state of partial deployment, with a pusher hole rotated to align with the element of the stabilizing element.

[0054] FIG. 14 shows the flat metal pattern of the fastener of FIG. 1A prior to molding into a fastener according to the present invention.

[0055] FIG. 15 shows the flat metal pattern of the fastener of FIG. 3A prior to molding into a fastener according to the present invention.

[0056] FIG. 16 shows a flat metal pattern prior to being formed into a fastener according to the present invention.

[0057] FIG. 17 shows one embodiment of a fastener in an expanded state according to the present invention.

[0058] FIG. 18A shows one embodiment of a core configured for the manufacture of a fastener according to the present invention.

[0059] FIG. 18B is a front view of the core of FIG. 18a.

[0060] FIG. 18C and 18D show the core coating (s) for use with the core of FIG. 18a.

[0061] The present invention is described and explained below with reference to the accompanying drawings. The drawings are appended as examples for understanding the present invention and schematically showing specific embodiments and details of the present invention. Drawings are not necessarily to scale. It is clear to the skilled person that other similar examples can easily be found, which also fall within the protection scope of the present invention. The drawings are not intended to limit the scope of protection of the present invention, which is defined in the attached claims.

IMPLEMENTATION OF THE INVENTION

[0062] The present invention relates generally to a fastener system, a deployment system and a method for percutaneous implantation of a fastener carrying a small implantable member into a patient's body. The system and method, in particular, relate to small fasteners having a volume, for example, in the range of 0.005-100 mm ³ , which are implanted into the wall of the target tissue in the patient's body. The dimensions of the fastener are determined by the wall thickness of the target fabric. However, the fastener may have an outer diameter in the range of 0.01-10 mm, height preferably not more than 20 mm and preferably can be made with the possibility of integration with a small implantable element having a diameter in the range of 0.01-10 mm and height in the range of 0.01-20 mm. It may be desirable for the element to be fully integrated into the positioning console of the fastener. The fastener is made of a trombone-forming, bio-decomposable, and biodegradable material, preferably such as a shape memory material, such as nitinol, stainless steel, or other suitable alloys or polymers. According to one embodiment, the fastener has an outer diameter of 1 mm, a height of less than 0.4 mm and provides for the integration of a small implantable element having a diameter of 0.8 mm and a height of 0.3 mm. One preferred target area for embedding a fastener, which may be based on the thickness of the blood vessels in the target area, may be not less than 0.5 mm and not more than 50 mm. Target areas of non-vessel target structures include, for example, a septum in the heart or the liver parenchyma, which may have thicknesses in the range of 0.5-10 mm.

[0063] The size and relatively low invasiveness of such fasteners make them particularly well suited for use in medical and physiological applications, including but not limited to measuring parameters of physiological fluids, such as, for example, in a blood vessel / artery / vein. In general, such fasteners can facilitate the measurement of chemical or physical parameters of physiological fluids, such as blood, urine, or digestive fluids. Heart implants, for example, can be used to measure pressure in the left atrium in cases of chronic heart failure. Liver implants can be used to measure intra-abdominal pressure. Such fasteners are also suitable, for example, to facilitate the control of specific diseases, conditions or chemical or physiological parameters of the body, as well as for the delivery of a therapeutic drug, or in other similar situations.

[0064] The fastening element comprises a first stabilizing element, a second stabilizing element, a jumper located between the first and second stabilizing elements, the first ring, the second ring and the positioning console. Each of the first and second stabilizing elements contains one or more elements that can be made in various forms, such as, for example, teeth, coils, curls, etc. One such stabilizing element may be located at the proximal end of the fastening element (proximal stabilizing element), and another such stabilizing element may be located at the distal end of the fastening element (distal stabilizing element). Each of the first or second stabilizing elements has a compressed state in which it may have a shape, such as, for example, a spiral or a straight tooth in a compressed position, or, according to another embodiment, may have an irregular shape, having, for example, bends, loops or twists , or in general can be made of amorphous material. Each of the first or second stabilizing elements also has an expanded state in which, for example, its diameter is larger than the diameter of the hole in the wall of the target area created by the cannula during the delivery of the fastener. The wall of the target area is understood as the fabric on the deployment area, through which the fastener extends outward for deployment. Preferably, the tissue of the target site is an organ containing physiological fluids transported through it, for example, blood vessels, heart chambers, digestive organs, urinary tract organs, liver, etc. The elements of the first stabilizing element extend from the first ring, and the elements of the second stabilizing element extend from the second ring. The first ring and the second ring are connected by a jumper. The positioning console can extend from the first ring or from the second ring. The ring can be of any shape, including, round, and can be empty or filled.

[0065] The present invention also relates to a deployment system that is designed to deliver a fastener and includes a cannula for an input device having an internal lumen in which a pusher, a shell and a fastener are placed. In an additional embodiment, the deployment system may comprise a catheter system for intraluminal delivery of the fastener. According to one embodiment, the sheath surrounds the compressed fastener and supports the first and second stabilizing elements and the positioning console in a compressed position in the cannula of the input device. Thus, the first stabilizing element and the positioning console can be oriented at the distal end of the fastener, and the second stabilizing element can be oriented at the proximal end of the fastener after assembly in the deployment system. The clamped fastener is delivered to the right place using a cannula and a pusher in such a way that the jumper intersects the wall of the target section, with the first stabilizing element and the positioning console penetrating the target section. After placing the fastener in a given area, the casing is removed, which releases the first stabilizing element and the positioning console to transfer them from the compressed state to the target section so that the positioning console is located on one side of the wall of the target section. Then, the second stabilizing element is released from its compressed state on the other side of the wall of the target section and, thus, secures the fastening element in a fixed position in which it intersects the wall of the target section.

[0066] In an additional embodiment, the positioning console may be located at the proximal end of the fastening element and, thus, is positioned together with the second stabilizing element. In this case, the deployment system further comprises a catheter, and the fastener is deployed intraluminal in such a way that this fastener is installed in the target portion of the vessel wall, for example, inside the vessel. According to this embodiment, the cannula and the pusher are located at the distal end of the fastening element in the wall of the target area so that the first stabilizing element is located on the outside of the vessel wall. Then the shell is tightened and thereby enable the first stabilizing element to be deployed and then the second stabilizing element, and thus the entire fastening element is deployed.

[0067] According to another embodiment, the deployment system may comprise a catheter with a fastener accommodated therein. The positioning console may be located at the distal end of the fastener together with the first stabilizing element. According to this embodiment, the catheter can be advanced intraluminal in the first vessel to access the target site located in the second, adjacent vessel. After reaching the target site, the access device, for example, the needle can be used to gain access to the target site in the second vessel from the first vessel. After that, the fastener can be deployed in a second vessel with a positioning console extending into the second vessel. For example, this method can access the portal vein from the hepatic vein (intrahepatic access).

[0068] The present invention also relates to a method of using a deployment system comprising a cannula, a shell, and a fastener. The target location can be identified by fluoroscopy or ultrasound, and access can be obtained according to known access routes. The proposed method includes the steps according to which: (i) pushing the cannula toward the wall of the target site, (ii) inserting the cannula into the wall of the target site so that the tip of the cannula is in the inside of the wall of the target site, (iii) pushing the compressed fastener to the specified target site through the specified cannula and, thus, place a squeezed fastener between the inner and outer parts of the wall of the target site, (v) apply a force of controlled value to extract the shell to deploy the fastener system o element, (vi) release the first stabilizing element of the fastener in such a way that one or more elements of the first stabilizing element expand, (vii) release the second stabilizing element of the fastener in such a way that one or more elements of the second stabilizing element expand, and (viii) retrieve said cannula. According to another embodiment, the additional step involves slightly pulling the delivery system to completely release and unfold the first stabilizing element against the vessel wall.

[0069] The present invention also relates to an additional feature of a deployment system comprising a cannula for an input device having an internal lumen in which a pusher and a sheath enclosing a fastening element are placed, the pusher having one or more holes through which the first or second stabilizing the element extends outward into the space between the pusher and the cannula. The frictional force between the outer wall of the pusher and the inner wall of the shell holds the specified element in place until one way or another the friction force acting on the element, which is then released for deployment, is overcome. Thus, the deployment method of this embodiment further comprises the steps of: (a) removing a shell holding one or more elements of the second stabilizing element in place, and (b) removing the pusher to release one or more elements of the second stabilizing element passing through one or more holes in the pusher. According to another embodiment, each of the one or more pusher holes is L-shaped, composed by the neck of the hole and the shoulder of the hole. In position before deployment, the element of the second stabilizing element can pass through the shoulder of the opening. Thus, the deployment method of this embodiment further comprises the step of: (a) rotating the plunger so that the neck of the hole is aligned with the element of the second stabilizing element, and (b) removing the shell to release the element of the second stabilizing element.

[0070] The present invention further comprises a method of manufacturing a fastener, comprising the steps of: (i) making the wire of a suitable material and (ii) if necessary, apply heat treatment to the wire to give the wire a predetermined shape using a core. According to one embodiment, the core comprises a first disk having a groove, a second disk having a groove, and a shaft interposed between the first and second disks. Another method of manufacturing a fastener according to the present invention involves the steps of: (i) laser cutting a preselected template from a flat sheet of metal, such as, for example, nitinol, and (ii) forming a fastening element from the template, having a first stabilizing element, a second stabilizing element and jumper, located between the first and second stabilizing elements, by applying heat treatment, welding or mechanical force.

[0071] Various embodiments of the present invention are described below. It should be noted that the accompanying drawings are examples of features of the present invention, but are non-limiting. The specialist will easily find other options for implementation, which also fall within the protection scope of the present invention.

[0072] FIG. 1A shows one embodiment of a fastener according to the present invention. The fastener 110 includes a jumper 115, the first ring 119 and the second ring 118. From the first ring 119 passes the first stabilizing element 125, which is folded into a spiral in a compressed state, as well as the positioning console 130, located in a spiral formed by the first stabilizing element 125. From the second ring 118 passes the second stabilizing element 120, which is coiled into a spiral in a compressed state. Positioning console 130 may extend from the first or second ring, depending on how the fastener is delivered. If the fastener is delivered directly to the target site using only a cannula (for example, extra lumenary), the positioning console is preferably connected to the second ring. Each of the first stabilizing element 125 and the second stabilizing element 120 is formed from the element shown in FIG. 1A. The element may be made in the form of wire, tape, strip, or may have another appropriate configuration to perform the function described in this application. In the embodiment shown in FIG. 1, the specified element is made in the form of a ribbon. As shown in FIG. 1A, the fastening element 110 is in a state before deployment, as in a delivery system in which the first stabilizing element 125, the second stabilizing element 120 and the positioning arm 130 are in a compressed state. In one embodiment, the ring associated with the positioning console may be larger than the other ring or vice versa, depending on the configuration of the pusher.

[0073] The jumper 115 may have any desired length depending on the wall thickness of the target area. The length of the jumper must be selected so that the first ring 119 and the first stabilizing element 125 can pass into the lumen of the target area, and thus it should be possible to expand the first stabilizing element 125 (in this embodiment, by partially unfolding the compressed helix), while the second ring 118 and the second stabilizing element 120 remain on the outside of the wall of the target area, and the second stabilizing element must also be provided ent 120. In FIG. 1B shows the fastener 110 shown in FIG. 1A in a fully expanded state. FIG. 1B shows a fastener 110 implanted into the tissue 150 of the vessel.

[0074] According to another embodiment, the first and second stabilizing elements 125, 120 can be adapted to adapt after their deployment to the wall, which can be of different thickness, for example, passing at an angle relative to the parallel wall of the target area on both sides in such a way that the far end of each stabilizing element is located closer to the wall of the target area than the point at which each specified stabilizing element is connected to the ring, to compensate for if the length of sliver significantly exceeds the wall width of the target area.

[0075] FIG. 2A shows another embodiment of the fastening element 210 in a compressed state, according to which the first stabilizing element has a first element 225a and a second element 225b, and also the second stabilizing element has a first element 220a and an element 220b. The first element 225a and the second element 225b of the first stabilizing element are arranged around the first ring 219 and are wound parallel to each other. Similarly, the first element 220a and the second element 220b of the second stabilizing element are located at 180 ° angular separation on the second ring 218 and are wound parallel to each other. According to another embodiment, said stabilizing elements can form a helical configuration shown in FIG. 2A, in which each of the first and second elements of each stabilizing element is formed from a continuous loop so that the spiral coil of each stabilizing element does not contain blunt ends, i.e., each stabilizing element forms a double helix. FIG. 2B shows the fastener 210 in a fully unfolded state, in which each of the first and second elements 225a, 225b of the first stabilizing element and the first and second elements 220a, 220b of the second stabilizing element is fully unfolded. The expanded configuration is characterized as containing stabilizing elements that extend in a direction substantially perpendicular to the web of the fastener in such a way that the fastener is fully deployed, for example, to a diameter that is larger than the diameter of the hole created by the cannula .

[0076] FIG. 3A shows another embodiment of the fastener 310 in a pre-deployment condition, in which the first stabilizing element comprises the first element 325a, the second element 325b and the third element 325c, and the second stabilizing element contains the first element 320a, the second element 320b and the third element 320c. In the state before deployment, the first, second and third elements 325a, 325b, 325c of the first stabilizing element extend approximately directly from the first ring 318 towards the second ring 319; and the first, second and third elements 320a, 320b, 320c of the second stabilizing element extend approximately directly from the second ring 318 towards the first ring 319. As shown in FIG. 3A, the elements extend from one ring approximately straight towards the other ring. FIG. 3B shows the fastening element 310 in a fully expanded state, in which the first, second and third elements 325a, 325b, 325c of the first stabilizing element and the first, second and third elements 320a, 320b, 320c of the second stabilizing element are bent in the direction from the web 315.

[0077] Other forms of the first and second stabilizing elements can be used in connection with the fastening element, as shown, for example, in FIG. 4, in which the first stabilizing element 425 and the second stabilizing element 420 are shown in a compressed state, in which the first and second stabilizing elements 425, 420 are folded inward towards the center of the fastening element 410. In FIG. 5 shows a fastening element 510 comprising a first element 525a and a second element 525b of the first stabilizing element extending from the first ring 519 and folded inwardly in a compressed state, and the first element 520a and the second element 520b of the second stabilizing element, and also positioning the console 530 extending from the first ring 519, which are all folded inward in a compressed state. FIG. 6 shows a hybrid combination in which the first and second elements 625a, 625b of the first stabilizing element on the first ring 619 are rolled inward, and the first and second elements 620a, 620b of the second stabilizing element on the second ring 618 are also rolled inwards when fastening element 610 is in compressed state.

[0078] FIG. 7 shows a ring 770 that can be used at the proximal or distal end of a fastener, comprising a plurality of elements 775a-775d of a stabilizing element that are configured to bend inwardly in a compressed state, as shown in FIG. 7. The elements of the stabilizing element according to this embodiment can be configured to bend outward in various forms after the fastening element is deployed, as shown in FIG. 7A. In another embodiment, the stabilizing element extending from the ring 870 may comprise a plurality of elements, each of which forms a loop, for example, each of the first element 875a and the second element 875b may form a continuous loop extending outward in different directions, as shown in FIG. 8. In FIG. 8A shows a top view of various embodiments of a ring 870 containing coiled elements of a stabilizing element in a unfolded state. FIG. 17 shows another embodiment of the fastener 1710 in a fully expanded state.

[0079] In the embodiments shown in FIG. 9A-9C, lintel 915 of fastener 910 may be formed of an elastic or flexible material capable of stretching or compressing to accommodate the dimensions of the vessel wall in which the fastener is deployed. In another embodiment, the web can be positioned at an angle so that the angle can be adjusted after deployment according to the wall thickness of the fabric. According to this embodiment, the predetermined angle or degree of curvature of the web defines the thinnest wall of the fabric for reliable implantation of the fastener, while the full length of the web defines the thickest wall of the fabric. After compression and placement in the delivery system, the jumper can be straightened. After deployment, the fastener lintel will maintain a varying degree of contraction to match the wall thickness of the body tissue at the implantation site.

[0080] FIG. 9A shows the fastening element 910 in a semi-compressed state; FIG. 9B shows the fastener 910 in the expanded state, and FIG. 9C shows the fastener in a compressed state. FIG. 9D and 9E shows a fastener deployed in two different target tissues. Target fabric 920 shown in FIG. 9D is thinner than the target fabric 930 shown in FIG. 9E. After deploying a fastener jumper 915 in the target tissue 920, it can be reduced so that the first and second stabilizing elements 940 and 950 come into contact with the target tissue, as shown in FIG. 9D. After being deployed in target tissue 930, jumper 915 may be in a more expanded state, so that stabilizing elements 940 and 950 are also in contact with the target tissue, as shown in FIG. 9E. Elastic lintel 915 allows for reliable insertion of the fastener into target fabrics having different thicknesses.

[0081] the Present invention also relates to a deployment system designed for percutaneous delivery and reliable implantation of a fastener in the wall of the target area. FIG. 10 shows the cannula 1040 of an input device for the percutaneous delivery of a fastener having an internal lumen 1041 and a tip 1042. The cannula 1040 is adapted to accommodate a fastener 1010, a shell 1050 and a pusher 1060. The cannula 1040 may have an outer diameter in the caliber range 1-50 G, internal diameter in the range of 0.01-20 mm, length 1-200 cm and can be made of semi-rigid biologically compatible material suitable for use in the human body. Suitable materials include, for example, silicones, polyvinyl chloride (PVC) or other biocompatible polymers for medical purposes. In one particular embodiment, the cannula 1040 has an outer diameter (caliber) of 17 G, an inner diameter of 1.06 mm, a length of 20 cm, and is made of a semi-rigid biocompatible material. The fastening element 1010 is made in such a way that, in the compressed state, the first stabilizing element 1025 and the second stabilizing element 1020 have a sufficient diameter to pass into the internal lumen 1041 of the cannula 1040 without causing bulging.

[0082] The pusher 1060 is located in the lumen 1041 of the cannula 1040 and is directly brought closer to the fastener 1010. The pusher 1060 may have an outer diameter in the range from less than 0.01 to not more than 20 mm, a length in the range of 1-200 cm and the shape of an inverted the cone at the pushing end, and can be made to protect the area around the fastener 1010. The pusher 1060 is made with the possibility of longitudinal movement in the inner lumen 1041 of the cannula 1040 from the proximal end of the cannula 1040 to the target implantation site to deploy the fastening 1010. The pusher 1060 may be solid or contain suitable semi-rigid biocompatible material such as nitinol, silicone, polyvinyl chloride, titanium, or stainless steel. The materials of which the cannula 1040 is made and the pusher 1060 may be the same or different, provided that the pusher 1060 is made of a material sufficiently rigid to resist compression.

[0083] The fastening element 1010 is oriented such that the first stabilizing element 1025 and the positioning console 1030 are located at the distal end of the fastening element 1010 near the tip 1042 of the cannula 1040 and the second stabilizing element 1020 is located at the proximal end of the fastening element 1010. According to the embodiment shown in FIG. 10, in which the fastener is delivered directly to the target site using only a cannula (e.g., outside light), the positioning console 1130 is preferably oriented towards the distal end of the fastener.

[0084] The sheath 1050 extends over the fastener 1010 and is configured to be controlled by pulling to release the fastener 1010 in the deployment area. The shell 1050 may be retracted to unfold the fastener 1010, while the pusher 1060 remains stationary to accommodate the fastener 1010 on the target implant site. The operator can control the shell 1050 directly or remotely so that the fastening element 1010 is released from the shell 1050 at the discretion of the operating element. For example, the sheath 1050 may extend in the direction from the fastener 1010 through the inner lumen 1041 of the cannula 1040 of the input device to the proximal end, with the result that the operator is given the opportunity to control the sheath 1050 directly using mechanical means. In another embodiment, stabilizing elements may also be used to be detachable using materials with shape memory, such as nitinol or shape memory polymers, which can be controlled by known means, such as the thermal, light, chemical, magnetic or electrical stimulants described, for example, in U.S. Patent No. 6,720,402 and U.S. Patent No. 2009/0306767, both of which are fully incorporated into the present application by reference. For example, a material with a shape memory can be made in the form of a spring capable of contraction and expansion when an electric current is passed through or disconnected. Electroactive grade polymers or shape memory magnetic alloys can also be used in a similar way. In another embodiment, a remote control mechanism may be used, such as, for example, a string and a loop mechanism, in which the string passes through a loop or a hoop-like structure on the shell 1050, and the two ends of the string extend to the proximal end of the input cannula 1040. To check the reliability of the fastener insertion, you can pull at both ends of the string to ensure that the shell 1050 does not move. With the release of one end of the string out of the loop, and then the shell 1050 can be retracted. The shell 1050 may be of any suitable size or shape that allows it to be placed in the inner lumen 1041 of the cannula 1040. The shell 1050 may be formed from a woven polymer, such as polyimide, which can be woven together with a biocompatible material, such as silicone, polyvinyl chloride , titanium or stainless steel. The shell 1050 may be relatively less rigid than the pusher 1060.

[0085] The present invention also relates to a method for implanting a fastener into a wall of a target portion. The method comprises penetrating the cannula 1040 through the wall 1080 of the target area, as shown in FIG. 10. FIG. 10A shows the fastener 1010 in an early deployment phase, where force is applied to the pusher 1060, as a result of which the fastener 1010 extends into the target section 1090, sheath 1050 is fastened with the fastener 1010 and the first stabilizing element 1025 and the positioning console 1030 are deployed. element 1025 and the positioning console 1030 return to the unfolded state within the target region 1090, while jumper 1015 intersects the wall 1080 of the target region. The expanded state of the first stabilizing element 1025 can have any shape that extends the span of the coil in the perpendicular direction to the jumper axis, i.e., a configuration is generated that prevents the fastener from moving from its predetermined position in the wall of the target portion. Then, a small force is applied to the half-deployed fastening element 1010 acting in the opposite direction (i.e., pulled back to closely approach the wall of the target section) to ensure that the fastening element 1010 is properly embedded in the vessel and fully deployed. FIG. 10B shows the fastener 1010 in a fully unfolded state after the shell 1050 and cannula 1040 are completely removed, with the result that the second stabilizing element 1020 is unfolded from the compressed state and partially unwinds its helix. At the deployment stage, each of the first and second stabilizing elements forms a flattened coil configuration. Thus, the first stabilizing element 1025 is unwound along the outer wall 1081 of the target area, the web of the fastening element 1015 intersects the wall of the target section 1080, the second stabilizing element 1020 is unwound along the inner wall 1082 of the target section, and the positioning console 1030 returns to the pre-selected position for translating the fastening element in specific orientation relative to the target area according to the design specification. The cannula 1040, the shell 1050 and the pusher 1060 are completely removed from the fastening element 1010.

[0086] Preferably, the sheath has a feedback mechanism that ensures reliable implantation of the fastener prior to removal of the plunger. According to one embodiment, the feedback consists in transmitting to the operator a physical sensation of resistance of the released first ring, interacting with the inner wall of the vessel in the target implantation area. A physical sensation of resistance when attempting to remove a fastener signals the operator that the fastener is successfully deployed in the inside of the vessel and that the second ring can be released from the shell to fully deploy the fastener.

[0087] The force feedback mechanism may be configured to control the user by the shell, as described above. According to another embodiment, a force sensor can be used with the sheath to ensure reliable deployment of the fastener in the target area. The force sensor can be used to measure the magnitude of the force of the first stabilizing element in the unfolded position against the inner wall of the vessel after partially deploying the fastener and, thus, alerting the operator that the second stabilizing element can be released for full deployment. The force sensor can also be used to measure the magnitude of the pushing force used to pierce the vessel wall, as well as the magnitude of the pulling force exhibited by the fastener to ensure reliable interaction of the fastener in the body of the lumen, precluding premature displacement. One example of a force sensor that can be embedded in a system according to the present invention is described in US Patent Publication No. 2010/0024574, the contents of which are fully incorporated into the present application by reference.

[0088] According to one embodiment shown in FIG. 11, the pusher 1160 may be hollow, and the fastening element 1110 may be placed inside the pusher 1160 up to the first ring 1119. The pusher 1160 has an opening 1161 into which the second stabilizing element 1120 of the fastening element 1110 passes. As additionally shown in FIG. 12A, the shell 1250 covers the outside of the pusher 1260 and thus forms the trigger 1280, which compresses part of the second stabilizing element 1220 extending out through the opening 1261, between the pusher 1260 and the shell 1250. The trigger is preferable to prevent premature release of the stabilizer to deployment to the target site. FIG. 12B shows the result of pulling or releasing the shell 1250 from the pusher 1260, with the result that the second stabilizing element 1220 is released from the compressed state.

[0089] FIG. 13A-13B, another embodiment of the trigger mechanism 1380 is shown, according to which the pusher opening 1360 is L-shaped, formed by the opening shoulder 1361a and the opening neck 1361b. In the deployment position, the second stabilizing element 1320 extends into the shoulder 1361a, as shown in FIG. 13A. After rotation of the pusher 1360, the bore neck 1361b is aligned with the second stabilizing element 1320, as shown in FIG. 13B, and thus enables the second stabilizing element 1320 to be deployed by sheathing the shell 1350. Rotation of the pusher 1360 around the second stabilizing element 1320 is provided by the friction force of the first stabilizing element after it is deployed against the oppositely directed wall of the target area.

[0090] The deployment system described above can be used to implant a fastener into any available wall of body tissue, such as in the cardiovascular system, the portal venous system of the liver, or in the gastrointestinal tract. According to one embodiment, the present invention may be suitable for use in the portal venous systems of the liver during portal venous catheterization procedures for implanting a fastener into the portal vein. According to another embodiment, the arteries of the cardiovascular system can be controlled by implanting a small implantable element into these arteries or into some veins.

[0091] A small implantable element can control any physical characteristic in a cavity or lumen. Examples of such elements for measuring physical or chemical characteristics of a body include devices, such as, for example, sensors, gauges, attenuators, or regulators of intraluminal or out-of-luminal function. According to another embodiment, a small implantable element can process data about a medical condition, for example, with the introduction of a therapeutic drug.

[0092] According to any one of the embodiments described above, a fastener may comprise a radiopaque marker attached to a component of the fastener, for example, a positioning console. In another embodiment, the fastener may be partially or fully composed of a radiopaque material. Radiopaque material may include gold, boron, tantalum, platinum-iridium or similar materials. The use of radio-opaque materials provides the ability to visualize with fluoroscopy or ultrasound, or both.

[0093] The present invention further relates to a method for manufacturing a fastener element system, comprising the steps of: making a wire from a suitable material, such as, for example, nitinol, and applying heat treatment to said wire to give it a flattened shape for a thermomechanically unfolded configuration of the stabilizing element. Other manufacturing methods of the present invention include, for example, laser cutting, chemical etching, electrochemical machining, electrical discharge machining, or other known mechanized methods. The fastening element according to the present invention can be made from a flat metal sheet or blank pipe from a material, such as, for example, nitinol or stainless steel, in the form of a preselected template. Thus, the template can be wound using heat treatment, welding or mechanical force.

[0094] FIG. 14 shows the pattern of the fastener 110, for example, shown in FIG. 1A comprising a jumper 115 with a second end 116 and a first end 117. The second tape 111 is located at the second end 116 of the jumper 115 with a second stabilizing element 120 extending from it in a direction parallel to the jumper 115. The second tape 111 can be formed into a ring and welded ends together, and after heat treatment or processing in other ways, the second stabilizing element 120 can be configured to a state before deployment. The first tape 112 is located at the first end 117 of the web 115 with the first stabilizing element 125, as well as with the positioning console 130 extending from it in a direction parallel to the web 115 of the fastening element.

[0095] The positioning console 130 may be located at different locations of the first tape 112, for example, as shown in the drawing, without alignment with the jumper 115. The first tape 112 may be formed into a ring and joined by welding the ends together, and after heat treatment or other processing the first stabilizing element 125 may be configured in a state before deployment. FIG. 15 shows a laser-cut pattern of a fastener, for example, shown in FIG. 2A, comprising the first element 225a and the second element 225b of the first stabilizing element spaced 180 ° apart from the first element around the ring, and the first element 220a and the second element 220b of the second leveling element spaced the same angle distance from the first element. In another embodiment, the elements may be arranged differently around the tape. In another embodiment, the ends of the elements can be joined to form a continuous loop. FIG. 16 shows another laser-cut pattern, further comprising a third element 220c of the second stabilizing element. According to other embodiments, a different number of elements may be differently arranged along the belt, which is obvious to a specialist, and all such embodiments fall within the protection scope of the present invention.

[0096] FIG. 18A shows a core 1800 comprising a first disk 1810, a second disk 1820, and a shaft 1830 between them. As shown in FIG. 18B, the first disk 1810 has a first surface 1815 that has a bulge facing the second disk 1820, and a second disk 1820 similarly has a second surface 1825 that has a bulge facing the first disk 1810. Although FIG. 18A shows convex surfaces on the first and second disks, the present invention allows the use of other surface shapes, including flat or concave surfaces. In each of the first and second surfaces 1815, 1825, grooves 1816, 1826, respectively, are formed, spirally extending from the shaft 1830 toward the edges of the disks 1810, 1820.

[0097] The core coatings are configured to cover the core 1800, which can be of any shape or size. As shown in FIG. 18C, one coating 1850 is configured to cover approximately half of the surface area of the shaft 1830 and the first or second surface 1825 or 1826. The coating comprises a shaft cover portion 1860. FIG. 18D shows two coatings that cover substantially the entire shaft 1830 and the first and second surfaces 1825 and 1826. Despite the fact that FIG. 18C and 18D, two coatings 1850 are shown that are symmetrical; according to the present invention, the number, configuration, and size of coatings for the core are not limited to the embodiments shown in the drawing. The 1850 covers can be securely fastened around the core to any known fastening means, including latches or clamps. In addition, around the shaft cover portion 1860, a spindle-shaped wire can be wound to hold the coating 1850 securely on the core.

[0098] In the manufacturing process, a material, for example, a wire, forming a fastener is placed in the groove of the core. After placing the coating material is securely fixed to the core and, thus, limit the movement of the material. Then, the core-containing material, together with the coatings, is heat-treated in a known manner such that the material takes the form of a core groove. Materials placed in the grooves of the first and second surfaces form the first and second stabilizing elements, while the materials in contact with the shaft form the web and the first and second rings. Preferably, the material forming the ring is not connected to the ends in a round shape when it is placed in the core to allow removal of the fastener after heat treatment.

[0099] In the manufacture of an embodiment having a stretchable web, such as, for example, in the embodiments of the fastener shown in FIG. 9A-9E, the core may comprise a first disc, a second disc, and a shaft between them. The shaft according to this embodiment can be made with one or many bends in such a way that when the material is placed in the core and is heated, the resulting web has a bend (bends) in a relaxed state in accordance with the shape of the shaft. Similarly, the shape and size of the coatings for the core can be modified to provide an addition to the shaft profile of such a core.

[0100] After the molding described above, the fastener is removed from the core and subjected to additional machining processes, including welding, soldering, brazing, or attaching additional components, such as connecting the first and second rings, attaching the positioning console, or attaching a small implantable element.

[0101] It will be appreciated by those skilled in the art that various changes, additions, modifications, and other applications can be made in the present invention, in contrast to the specific embodiments shown and described in this application, without departing from the idea or scope of protection of the present invention. Although the present invention has been shown and described in this application by means of specific implementation options, it will be clear to those skilled in the art that various combinations of these implementation options or a combination of the specific features of these implementation options can also be used without departing from the idea or scope of protection of the present invention. Thus, it is considered that the scope of protection of the present invention, as defined in the claims of the claims, includes all visible modifications, additions, modifications or applications.

Claims (22)

1. Placement system for the percutaneous delivery and implantation of a fastener of an implantable element for monitoring and / or processing data on the physiological conditions of the patient’s body or for delivering a medicinal preparation containing an input device cannula, a hollow plunger having an opening, a shell and a fastener placed inside pusher and containing a proximal stabilizing element having a compressed configuration and a deployed configuration, a distal stabilizing element having a compressed configuration and times return configuration, a jumper between the proximal stabilizing element and the distal stabilizing element, the proximal stabilizing element passing through the hollow pusher opening in a compressed configuration, the fastening element having a positioning console for fastening the fastening element extending from the distal stabilizing element to which the implantable element is attached. 2. The system according to claim 1, in which the proximal stabilizing element is pressed against the outer surface of the pusher. 3. The system according to claim 2, in which the proximal stabilizing element is wound through the hole. 4. The system according to claim 1, in which the hole contains a slot extending along the longitudinal axis of the pusher. 5. The system according to claim 4, in which the hole contains a neck perpendicular to the slot. 6. The system according to claim 1, in which an implantable element is attached to the positioning console. 7. The system according to claim 6, in which the implantable element is a sensor. 8. The system according to claim 1, in which the fastening element has a height that is less than or equal to 20 mm, and the diameter, which is from 0.01 mm to 10 mm, in the unfolded configuration. 9. The method of assembling an accommodation system for the percutaneous delivery and implantation of a fastener of an implantable element for monitoring and / or processing data on the physiological conditions of the patient's body or for delivering a therapeutic agent containing a cannula, a shell, a hollow pusher with a hole and a fastener proximal stabilizing element, the distal stabilizing element and the jumper between them, according to the method: - load the fastener into the hollow plunger so that the proximal stabilizing element passes through the hole, and - promote the shell on the pusher and the proximal stabilizing element in order to press the proximal stabilizing element to the outer surface of the pusher. 10. The method according to claim 9, according to which the hole contains a slot and neck, while additionally turning the plunger to align the neck hole with a proximal stabilizing element. 11. The method according to claim 9, according to which the shell is additionally removed, removing the compression from the proximal stabilizing element. 12. Implantable fastener of an implantable element for monitoring and / or processing data on the physiological conditions of the patient’s body or for delivering a therapeutic agent containing a proximal stabilizing element extending from the proximal end to the distal end, a distal stabilizing element extending from the proximal end to the distal end, a jumper extending between the distal end of the proximal stabilizing element and the proximal end of the distal stabilizing element, and position A mounting console for attaching an implantable element extending from the proximal end of the distal stabilizing element, wherein the proximal and distal stabilizing elements have a compressed configuration and are configured to adopt a deployed configuration and the proximal end of the distal stabilizing element is distal relative to the distal end of the proximal stabilizing element. 13. The fastener according to item 12, which has a height less than or equal to 20 mm and a diameter that is from 0.01 mm to 10 mm, in the unfolded configuration. 14. The fastener element according to item 12, in which the positioning console has a compressed state and a deployed state. 15. The fastener according to item 12, in which the implantable element is attached to the positioning console. 16. The fastener according to claim 15, wherein the implantable element is a sensor. 17. The fastener element according to claim 12, which further comprises a first ring at the distal end of the web and a second ring at the proximal end of the web. 18. The fastener according to claim 17, wherein the distal stabilizing element and the positioning arm extend from the first ring and the proximal stabilizing element extends from the second ring. 19. The fastener according to claim 17, wherein the first ring is larger than the second ring. 20. Implantable fastener of an implantable element for monitoring and / or processing data on the physiological conditions of the patient’s body or for delivering a therapeutic agent containing a proximal stabilizing element extending from the proximal end to the distal end, a distal stabilizing element extending from the proximal end to the distal end a jumper extending between the distal end of the proximal stabilizing element and the proximal end of the distal stabilizing element, and position The mounting bracket for attaching the implantable element extending from the proximal end of the distal stabilizing element, wherein the positioning console is distal relative to the distal end of the proximal stabilizing element, wherein the proximal and distal stabilizing elements have a compressed configuration and are configured to adopt the unfolded configuration.

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